NCT05996848CompletedPhase 3
A Research Study to See How Well CagriSema Helps People in China With Excess Body Weight Lose Weight
Efficacy and Safety of Cagrilintide s.c. 2.4 mg in Combination With Semaglutide s.c. 2.4 mg (CagriSema s.c. 2.4 mg/2.4 mg) Once-Weekly in Chinese Participants With Overweight or Obesity
Source: ClinicalTrials.gov · Last updated 9 Jan 2026
Brief summary (registry, in English)
This study will look at how well the new medicine CagriSema helps people with excess body weight losing weight compared to a "dummy" medicine and a medicine called semaglutide. Participants will either get CagriSema, a dummy medicine or semaglutide. Which treatment participants get is decided by chance. Participants will take one injection once a week. The study medicine will be injected briefly with a thin needle, typically in the stomach, thighs or upper arms. The study will last for about 1 year.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 300 (actual)
- First submitted
- 10 Aug 2023
- Start date
- 15 Aug 2023
- Primary completion date
- 6 Jan 2025
- Lead sponsor
- Novo Nordisk A/S
- Diseases
- Obesity
- NCT number
- NCT05996848
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 300
- From 15 Aug 2023 to the primary completion date, 6 Jan 2025
- 36 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Clinically significant or severe hypoglycaemia within 6 months before screening or history of hypoglycaemia unawareness
- Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination
Other illness
- History of type 1 or type 2 diabetes mellitus
- For participants with T2D at screening:
Lab values
- HbA1c greater than or equal to 6.5 percent (48 mmol/mol) as measured by the central laboratory at screening
- Renal impairment with estimated glomerular filtration rate (eGFR) lesser than 30 milli liter per min/1.73 meter square (mL/min/1.73 m\^2), as measured by the central laboratory at screening
Other
- For participants without T2D at screening:
Who the study is looking for
- Male or female
- Age above or equal to 18 years at the time of signing informed consent
- Body Mass Index (BMI) greater than or equal to 30.0 kilograms per square meter (kg/m\^2) or
- BMI greater than or equal to 27.0 kg/m\^2 with the presence of at least one weight-related comorbidity including, but not limited to, type 2 diabetes mellitus, hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease
- For participants with Type 2 diabetes (T2D) at screening the following criteria also apply:
- Diagnosed with type 2 diabetes mellitus greater than equal to 180 days before screening
- Treatment with either lifestyle intervention, or treatment with 1-3 marketed oral antidiabetic drugs (OADs) (metformin, α-glucosidase inhibitors (AGI), glinides, sodium-glucose cotransporter 2 inhibitor (SGLT2i)), thiazolidinediones, or sulphonylureas (SUs) as a single agent or in combination) according to local label
- Treatment with oral antidiabetic drugs should be stable (same drug(s), dose and dosing frequency) for at least 60 days before screening
- Glycated Haemoglobin (HbA1c) 7 percent-10 percent (53-86 millimoles per mole \[mmol/mol\]) (both inclusive) as measured by the central laboratory at screening
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (36)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chinese People's Liberation Army General Hospital-Endocrinology Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| The First Bethune hospital of Jilin University-Endocrinology Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
| The First Hospital of Jilin University Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
| The First People's Hospital of Changde City-Endocrinology Coordinator of this site? Confirm its status | Changde | China | Unknown status |
| The First People's Hospital Of Changzhou Coordinator of this site? Confirm its status | Changzhou | China | Unknown status |
| Changzhou No.2 People's Hospital Coordinator of this site? Confirm its status | Changzhou | China | Unknown status |
| Chongqing University Three Gorges Hospital Coordinator of this site? Confirm its status | Chongqing | China | Unknown status |
| Fujian Medical University Union Hospital-Endocrinology Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
| Hengshui People's Hospital (Harrison International Peace Hospital)-Endocrinology Coordinator of this site? Confirm its status | Hengshui | China | Unknown status |
| Huizhou Central People's Hospital-Endocrinology Coordinator of this site? Confirm its status | Huizhou | China | Unknown status |
| Jinan Central Hospital Coordinator of this site? Confirm its status | Ji'nan | China | Unknown status |
| Jinan Central Hospital Coordinator of this site? Confirm its status | Jin'an | China | Unknown status |
| Jinan Central Hospital Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| Huashan Hospital Fudan University Coordinator of this site? Confirm its status | Jingan/Shanghai | China | Unknown status |
| Huaihe Hospital of Henan University Coordinator of this site? Confirm its status | Kaifeng | China | Unknown status |
| Huaihe Hospital of Henan University-Endocrinology Coordinator of this site? Confirm its status | Kaifeng | China | Unknown status |
| The First Affiliated Hospital of Henan University of Science Coordinator of this site? Confirm its status | Luoyang | China | Unknown status |
| The First Affiliated Hospital of Henan University of Science and Technology-Endocrinology Coordinator of this site? Confirm its status | Luoyang | China | Unknown status |
| The Second Affiliated Hospital of Nanjing Medical University Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| Tongren Hospital Shanghai Jiao Tong Univ. School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Central Hospital of Minhang District-Endocrinology Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Huashan Hospital, Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Tongren Hospital Shanghai Jiao Tong University School Of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Central Hospital of Minhang District, Shanghai-Endocrinology Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Shanghai Pudong New Area People's Hospital-Endocrinology Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| The Second Hospital of Hebei Medical University Coordinator of this site? Confirm its status | Shijiazhuang | China | Unknown status |
| The Second Hospital of Hebei Medical University-Endocrinology Coordinator of this site? Confirm its status | Shijiazhuang | China | Unknown status |
| The First Affiliated Hospital of Soochow University-Endocrinology Coordinator of this site? Confirm its status | Suzhou | China | Unknown status |
| Suzhou Municipal Hospital-Endocrinology Coordinator of this site? Confirm its status | Suzhou | China | Unknown status |
| General Hospital of Tianjin Medical University Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| General Hospital of Tianjin Medical University-Endocrinology Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| The Second Hospital of Tianjin Medical University Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| The affiliated hospital of xuzhou medical university Coordinator of this site? Confirm its status | Xuzhou | China | Unknown status |
| The Second Affiliated Hospital of Zhengzhou University-Endocrinology Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
| The Second Affiliated Hospital of Zhengzhou University Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
| The Affiliated Hospital of Jiangsu University Coordinator of this site? Confirm its status | Zhenjiang | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.